System with a surgical needle and a handle

ABSTRACT

In a system with a surgical needle ( 10 ) and a handle ( 20 ), the surgical needle ( 10 ), in its proximal end region opposite the needle tip, comprises a support section which is adapted to be pushed in the handle ( 20 ). The handle ( 20 ) includes a lumen adapted to support the support section of the surgical needle ( 10 ) and a locking means ( 30, 26 ), which can be adjusted from a locking position, in which the support section is secured to the handle ( 20 ), to a release position, in which the support section can be pulled out of the lumen.

CROSS REFERENCE TO RELATED APPLICATION

[0001] The present invention claims the benefit of earlier-filed U.S.provisional patent application, serial No. 60/242,271, filed on Oct. 20,2000, which is hereby incorporated by reference in its entirety herein.

FIELD OF THE INVENTION

[0002] The invention relates to a system with a surgical needle and ahandle.

BACKGROUND OF THE INVENTION

[0003] There are surgical operation techniques in which thick or verythick surgical needles are used, e.g., needles having a diameter from 2mm to 7 mm. For example, such needles are used in order to insert a bandor tape below the urethra of a patient for treatment of stressincontinence as disclosed in U.S. Pat. No. 5,899,909 and U.S. patentapplication 09______, both incorporated by reference herein in theirentirety.

[0004] When the needle is guided through tissue, considerable forcesoccur. In handling the needle, the surgeon can use a needle holder or agripper-like surgical instrument as an aid, but, as a rule, he has tore-apply this instrument to the needle often, which is not convenient.Moreover, unfavorable lever ratios can occur, in particular if theinstrument runs oblique with respect to the needle.

SUMMARY OF THE INVENTION

[0005] It is an object of the invention to provide a possibility forfacilitating the handling of a surgical needle, in particular of a thicksurgical needle.

[0006] The system according to the invention includes a surgical needleand a handle. The surgical needle comprises, in its proximal end regionopposite the needle tip, a support section, which is adapted for pushinginto the handle. The handle comprises a lumen adapted for holding thesupport section of the surgical needle and a locking means. The lockingmeans can be switched from a locking position, in which the supportsection is fixed to the handle, to a release position, in which thesupport section can be pulled out of the lumen.

[0007] When the support section is locked or fixed at the handle, thesurgical needle is rigidly and securely connected to the handle. In thisstate, the handle appreciably facilitates the handling of the needle.For example, by means of the handle, the needle can be held and easilyguided through the tissue of the patient. The suture material, tape or asimilar object, which is to be pulled through the tissue by means of theneedle, can be attached to the shaft of the surgical needle in betweenthe support section and the needle tip, preferably close to the supportsection, by means of a shrink tubing or other attachment and detachmentmeans as is disclosed in U.S. Pat. No. 6,273,852 B1, incorporated byreference herein in its entirety. If shrink tubing is used as theattachment means, the surgical needle preferably comprises an attachmentsection for suture material, a tape or similar means, distal to thesupport section, e.g. a corrugated section of the shaft which can alsobe provided with a step at which the shrink tubing engages in order toenable a continuous transition between the shaft and the suturematerial, the tape or similar means.

[0008] When using the invention for the method disclosed in the U.S.Pat. No. 5,899,909 patent, after the needle has penetrated the abdomenthe needle tip can be grasped by the surgeon by hand (or with aconventional instrument). At this moment, the locking means can beswitched from the locking position to the release position, such thatthe needle can be pulled out of the handle non-abruptly and with a smallforce effort (or, vice versa, the handle can be retracted from theneedle). After releasing the handle, the needle with the suturematerial, tape or similar means attached to the needle can be completelypulled through the tissue.

[0009] The surgical needle can have a diameter of 2 mm to 7 mm, but adifferent diameter is conceivable as well. Certainly, as is known tothose skilled in the art, the surgical needle may take on any variety ofcross-sections.

[0010] Preferably, the support section of the surgical needle, in itscross-section, at least in a partial region deviates from a circularshape, and the lumen, in its cross-section, is adapted to the supportsection for securing the surgical needle against torsion. This designenables a torsion-proof connection of the needle to the handle in asimple manner.

[0011] In an advantageous version of the invention, the lumen starts atan opening in the distal end region of the handle, and the supportsection of the surgical needle is adapted to a longitudinal insertioninto this opening. The support section of the surgical needle comprisesa depression, into which, in the locking position, engages a lockingelement provided at the locking means of the handle. The locking meanscomprises a sleeve rotatably mounted in the lumen of the handle. In thispreferred embodiment, there is provided at the proximal end of thesupport section of the surgical needle adjacent to the depression of thesupport section, a locking protrusion having a non-circularcross-sectional shape. The sleeve of the locking means is rotatablearound the longitudinal axis of the lumen from the locking position intothe release position and comprises a plate-like locking element havingan opening which can be passed by the locking protrusion in the releaseposition, but not in the locking position. Preferably, the lockingelement is located in the distal end region of the sleeve. The sleevecan be coupled to an actuating lever, which essentially runs in radialdirection, the free end of the actuating lever preferably extendingthrough an opening in the handle, which opening allows a rotationalmovement of the actuating lever and sleeve. The handle can include anengagement means for securing the actuating lever in the lockingposition.

[0012] This preferred embodiment of the invention allows a convenientand safe handling of the surgical needle with one hand. If required, theactuating lever can be moved into the release position, e.g., by meansof the thumb, such that the surgical needle can be released from thehandle with a small force and virtually without a jerk. Thus, thesurgeon requires one hand only in order to operate the system. Anotheradvantage of this embodiment is that it can be immediately recognized bymeans of the position of the actuating lever whether the locking meansis in the locking position or the release position.

[0013] Preferably, the handle is made from synthetic material and can bedesigned as a disposable article. Preferably, the handle has a two-partcasing such that the locking means can be easily assembled.

[0014] In a preferred embodiment of the invention, the handle, in thearea of its proximal end, comprises at least one broadening structure,e.g., two protrusions, which extend into opposite directions andtransversely with respect to the surgical needle, which protrusionsenable the handle to rest conveniently in the surgeon's palm or ball ofthe thumb. The handle can additionally comprise at least one fingerapplication structure, e.g. two wing-like structures extending intoopposite directions, which run in parallel to the broadening structuresand by means of which the surgeon, e.g. using the index finger and themiddle finger, can pull the handle onto his palm such that it securelyrests in his hand. Another advantage of this embodiment becomes apparentwhen the needle is curved. In this case the surgeon can recognize thedirection of the leading (distal) end of the needle area in relation tothe position of the broadening structure or the finger applicationstructure.

[0015] These and other features and advantages of the present inventionwill become apparent from the following more detailed description, whentaken in conjunction with the accompanying drawings which illustrate, byway of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In the following, the invention is explained in more detail bymeans of embodiments.

[0017]FIG. 1 is a perspective view of the proximal end region of thesurgical needle in an embodiment of the system according to theinvention;

[0018]FIG. 2 is a perspective view of the handle in the embodiment ofthe system according to the invention;

[0019]FIG. 3 is a perspective view of the distal region of the handlewhen the casing is opened and the surgical needle is inserted;

[0020]FIG. 4 is a perspective view of the locking means of the handle inthe embodiment of the system according to the invention;

[0021]FIG. 5 is a perspective view of the lower casing part of thehandle with the locking means inserted;

[0022]FIG. 6 is a detailed view of the locking handle;

[0023]FIG. 7 is an elevation view of the distal end face of the sleeveof the locking means;

[0024]FIG. 8 is a schematic longitudinal sectional elevation viewillustrating the release position of the locking means, the plane of thepaper being given by the direction of the axis I from FIG. 3;

[0025]FIG. 9 is a schematic longitudinal sectional elevation viewillustrating the locking position of the locking means, the plane of thepaper being given by the direction of the axis II from FIG. 3;

[0026]FIG. 10 a perspective view of the handle of a second embodiment ofthe system according to the invention;

[0027]FIGS. 11a-d are several views of a third embodiment of the systemaccording to the invention, i.e. (a) an elevation view from the distalend of the handle (b) a plan view of the handle, (c) an elevation view,and (d) a schematic exploded view; and

[0028]FIG. 12a-d are several views of a fourth embodiment of the systemaccording to the invention, i.e. (a) an elevation view from the distalend of the handle, (b) a plan view of the handle, (c) an elevation viewfrom the proximal end of the handle, and (d) an elevation view.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0029] Before explaining the present invention in detail, it should benoted that the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description, because the illustrativeembodiments of the invention may be implemented or incorporated in otherembodiments, variations and modifications, and may be practiced orcarried out in various ways. Furthermore, unless otherwise indicated,the terms and expressions employed herein have been chosen for thepurpose of describing the illustrative embodiments of the presentinvention.

[0030]FIG. 1 illustrates in a perspective view the proximal end regionof a surgical needle 10, which is one component of an embodiment of thesystem with a surgical needle and a handle. The needle tip, which islocated at the distal end of the needle 10, is not shown in FIG. 1. Ashaft 11, joins to the needle tip. In its proximal end region, theneedle 10 comprises a support section 12.

[0031] An attachment section 13, which, in the embodiment, has a conicalbasic shape (the diameter increasing in the proximal direction) and isprovided with a corrugation 14, is located between the shaft 11 and thesupport section 12. At the transition between the shaft 11 and theattachment section 13, there is formed a step or shoulder 15. At theattachment section 13, e. g. a tape can be attached, e.g. by means ofshrink tubing, which is to be secured in the tissue of a patient bymeans of the surgical needle 10. The step 15 provides for a smoothchange of the cross-section between the needle 10 and the shrink tubingor the tape at the transition site. Alternative means may be provided toattach the tape at both the proximal end and the distal end of theneedle 10.

[0032] The support section 12 has a cross-sectional shape with two flatportions, from which one can be seen in FIG. 1 and is designated by 16.A locking protrusion 17, the cross-sectional shape of which coincides tothat in the distal region of the support section 12, is located at theproximal end of the support section 12; the cross-sectional shapecorresponds to the area 34 in FIG. 7. The locking protrusion 17 has twoflat portions as well, from which one is designated by 18 and can beseen in FIG. 1. Adjacent to the locking protrusion 17 in distaldirection, there is a depression 19. In the embodiment, thecross-sectional shape of the needle 10 is circular in the area of thedepression 19, the diameter corresponding to the distance between bothflat portions 18 of the locking protrusion 17.

[0033] Preferably, the surgical needle 10 is integrally made and, in theregion of the shaft 11 and the needle tip, can have any form suitable tothe desired application.

[0034]FIGS. 2 and 3 illustrate a handle 20, which is another componentof the system. In the area of its proximal end, the handle 20 isprovided with two broadening structures 22, which cause the handle torest well in a surgeon's hand. A duct or lumen, into which the supportsection 12 of the needle 10 can be pushed, is located in the distal endregion 24 of the handle 20, as explained below in detail. In the viewsaccording to FIGS. 2 and 3, the needle 10 is inserted in the handle 20such that only the attachment section 13 and the shaft 11 only of theneedle 10 are not inserted into the handle 20. In the middle area of thehandle 20, an actuating lever 26 functions as a locking means for easilylocking and unlocking the needle 10, as discussed below. In theembodiment, the handle 20 is made from synthetic material and has acasing with a lower casing part 28 and an upper casing part. It isdesigned as a disposable article. A reusable handle, however, isconceivable as well.

[0035]FIG. 3 shows the distal region of the lower casing part 28 with asurgical needle 10 inserted. The lower casing part 28 includes, in itsdistal end region 24, a lumen running in the longitudinal direction ofthe handle 20, which lumen is closed in circumferential direction andopen at the distal end face of the handle 20 and at the proximal end ofthe lumen. The cross-sectional shape of this lumen is adapted to that ofthe support section 12, its length corresponds to that of the flatportion 16. Thus, the support section 12 of the needle 10 can be pushedinto the lumen from the distal end face of the handle 20 and thereaftersection 12 is supported in the lumen in a torsion-proof manner. As canbe seen in FIG. 3, the depression 19 and the locking protrusion 17 areexternal to the lumen when the needle 10 is inserted into handle 20.

[0036] Joining to the lumen in proximal direction, there is formed achannel 29 in the lower casing part 28, as indicated in FIG. 3. Thechannel 29 is accessible when the casing of the handle 20 is opened. Inthe assembled state of the handle, a sleeve 30 (see FIG. 4) is mountedbetween the channel 29 and a similarly designed channel in the uppercasing 38 (FIG. 6) such that the sleeve 30 can be rotated around thelongitudinal axis of the channel 29 between a locking position and arelease position.

[0037] As shown in FIG. 4, the sleeve 30 has a circular cross-section.At its distal end face, the sleeve 30 is designed as a plate-likelocking element 32, which is provided with an opening 34. The opening 34(see also FIG. 7) is adapted with respect to the shape of thecross-sectional shape of the locking protrusion 17 such that the lockingprotrusion 17 can pass through the opening 34 if the flat portions 18and the corresponding flat portions of the opening 34 are aligned withrespect to each other. In the assembled state of the handle 20, thedistal end of sleeve 30 abuts at the proximal end of the lumen for thesupport section 12 such that the depression 19 is located in the area ofthe locking element 32; the thickness of the locking element 32 isadapted to the length of the depression 19.

[0038] The actuating lever 26 extends from the proximal end region ofthe sleeve 30 and runs generally in radial direction. FIG. 5 shows thelower casing part 28 of the handle with the sleeve 30 inserted. In thedetailed view of FIG. 6, the upper casing 38 is shown. It can berecognized that the free end of the actuating lever 26 projects throughan opening 39 in the upper casing 38. The opening 39 allows a rotatingmovement of the actuating lever 26 by about 90° such that, by adjustingthe actuating lever 26, the sleeve 30 can be rotated from the lockingposition to the release position. In FIG. 6, the actuating lever 26 isin the locking position, wherein an engagement protrusion 36 (see FIG.4) is located in a corresponding depression at the upper casing part 38such that the actuating lever 26 is secured against an unintentionalmovement. This lock can be overcome when a larger force is applied suchthat the actuating lever 26 can be rotated to the release position.

[0039]FIG. 7 displays the distal end of the sleeve 30 with the lockingelement 32 and the opening 34.

[0040] In FIGS. 8 and 9, the mode of operation of the locking means isillustrated. In the state shown in FIG. 8, the sleeve 30 is in therelease position, wherein the locking element 32 is aligned with respectto the opening 34 and thus fits therethrough. The locking position isshown in FIG. 9. It can be recognized that the depression 19 is locatedin the area of the locking element 32 and that the locking protrusion 17prevents the needle 10 from being pulled out. The locking position isachieved by rotating the sleeve 30 by about 90°. It has to be noticedthat in the sectional representation according to FIG. 9 the plane ofthe paper has been rotated by 90′ as well (see also FIG. 3) such thatseemingly the needle 10 has been rotated and not the sleeve 30.

[0041]FIG. 10 shows a variant of the handle, which is designated by 20′.In addition to both broadening structures 22, the handle 20, has twofinger application structures 40 which enable an even more convenienthandling. The surgeon can grasp the handle 20′ such that the broadeningstructures 22 are positioned in his palm whereas his index finger andhis middle finger grip around the finger application structures 40 andthus slightly press the handle 20 against the palm. Therefore, thehandle 201 rests more economically and safely in, the hand of thesurgeon. The actuating lever 26 can be rotated with the thumb of thesame hand. Thus, a convenient actuation with one hand is possible.

[0042] As explained above, the handle 20 appreciably facilitates theguidance and use of the surgical needle 10 inserted into the handle 20.When the actuating lever 26 is in the locking position, the handle 20and the needle 10 are firmly connected to each other. If, however, thehandle 20 obstructs the further application of the needle 10 and theneedle 10 has to be released, the actuating lever 26 can be easilyrotated into the release position such that the needle 10 and the handle20 can be separated by a relative motion in longitudinal directionwithout problems and jerks.

[0043]FIG. 11 shows several views of a third embodiment of the systemaccording to the invention, i.e. (a) from the top, (b) from the front,(c) from the side, and (d) in a schematic explosion view. The needle,again designated by 10, is similarly designed as before, whereas thehandle, designated by 50, has a particular ergonomic shape with onelateral broadening structure 52 only. The handle 50 comprises two casingparts 54 and 55 inside which a sleeve 56 is mounted in a rotatablemanner which is designed similar as in the first two embodiments. Anactuating lever 58 is accessible through an opening 59 in the casingpart 55 in order to rotate the sleeve 56 from the locking position intothe release position.

[0044]FIG. 12 displays several views of a fourth embodiment of thesystem according to the invention, i.e. (a) from the top, (b) from theside, (c) from the front, and (d) from below. Again, the needle isdesignated by 10. The handle, provided with the reference numeral 60,comprises a gripping bow 62 as a broadening structure. The casing is intwo-part form again with casing parts 64 and 65. A lever 66 serves as anactuating lever of a rotatable sleeve, which is similarly designed as inthe previous embodiments and is not shown in FIG. 12. The lever 66 isarranged at the end of the sleeve.

[0045] It will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without departing from the spirit and scope ofthe invention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

1. A handle for accepting a surgical needle for use in surgical procedures, the handle comprising: a lumen for accepting a portion of the surgical needle; and locking means having a first position for locking the surgical needle within the lumen and a second position allowing the surgical needle to be placed within or removed from the lumen.
 2. A handle and surgical needle combination for use in surgical procedures, the handle comprising: a lumen for accepting a portion of the surgical needle; and a locking means having a first position for locking the surgical within the lumen and a second position allowing the surgical needle to be placed within or removed from the lumen; and the needle comprising: a first portion having a circular cross-sectional area; a second portion having a noncircular cross-sectional area for insertion into the lumen.
 3. The combination of claim 2 wherein the lumen has in part a cross-sectional shape adapted to receive the second portion for securing the surgical needle against rotational motion.
 4. The combination of claim 2, wherein the lumen has an opening at the distal end of the handle and the section portion of the surgical needle is adapted to longitudinally insert into the lumen.
 5. The combination of claim 2, wherein the second portion of the surgical needle comprises a depression, which engages, in the first position, a locking element provided at the locking means.
 6. The combination of claim 5, wherein the locking means comprises, in an interior space of the handle, a rotatably mounted sleeve.
 7. The combination of claim 6, wherein the locking element is positioned at the distal end region of the sleeve.
 8. The combination of claim 6, wherein the sleeve is coupled to an actuating lever.
 9. The combination of claim 8, wherein the actuating lever extends through an opening in the handle.
 10. The combination of claim 2, wherein the locking means comprises an actuating means, and said actuating means extends through an opening in the handle.
 11. The combination of claim 2, wherein the handle comprises a two-part casing.
 12. The combination of claim 2, wherein the proximal end of the handle comprises at least one broadening structure.
 13. The combination of claim 2, wherein the first portion of the needle comprises an attachment means for a suture material or mesh tape.
 14. The combination of claim 13, wherein the attachment means is located at the distal end of the surgical needle.
 15. A handle and surgical needle combination for implanting a tape to treat female urinary incontinence, the handle comprising: a lumen for accepting a portion of the surgical needle; and a locking means having a first position for locking the surgical within the lumen and a second position allowing the surgical needle to be placed within or removed from the lumen; and the needle comprising: a first portion having attachment for accepting the tape; a second portion having a noncircular cross-sectional area for insertion into the lumen.
 16. The combination of claim 15 wherein the second portion of the surgical needle comprises a depression, which engages, in the first position, a locking element provided at the locking means.
 17. The combination of claim 15, wherein the locking means comprises an actuating means, and said actuating means extends through an opening in the handle.
 18. The combination of claim 13, wherein the attachment means is located at the distal end of the surgical needle.
 19. A method for treating female urinary incontinence comprising the steps of: a) providing a curved needle element defining in part a curved shaft having a distal end and a proximal end; a tape for attaching to the needle; and a handle having a lumen for accepting a portion of the surgical needle and a locking means having a first position for locking the needle within the lumen and a second position allowing the needle to be placed within or removed from the lumen; b) locking the needle to the handle c) passing the needle into the body on one side of the urethra; d) attaching the tape to the needle and passing the needle and tape through the body; e) passing the needle into the body on the opposite side of the urethra; and f) attaching the tape to the needle and passing the needle and tape through the body to form a sling beneath the urethra.
 20. The method of claim 19 wherein the needle is passed into the body in step (c) via the vagina.
 21. The method of claim 19 wherein the needle is passed into the body in step (c) via the abdomen.
 22. A kit for treating female urinary incontinence comprising: a) at least one curved needle element defining in part a curved shaft having a distal end and a proximal end b) a tape for attaching to the needle; and c) at least one handle having a lumen for accepting a portion of the surgical needle and a locking means having a first position for locking the needle within the lumen and a second position allowing the needle to be placed within or removed from the lumen.
 23. A method for treating female urinary incontinence comprising the steps of: a) providing a first and second curved needle element each defining in part a curved shaft having a distal end and a proximal end; a tape for attaching to the needle; and a handle having a lumen for accepting a portion of the surgical needle and a locking means having a first position for locking the needle within the lumen and a second position allowing the needle to be placed within or removed from the lumen; b) passing the first needle into the body on one side of the urethra; c) attaching the tape to the distal end of the first needle and passing the first needle and tape through the body; d) passing the second needle into the body on the opposite side of the urethra; and e) attaching the tape to the distal end of the second needle and passing the needle and tape through the body to form a sling beneath the urethra.
 24. The method of claim 23 wherein the needles are passed into the bodys in steps (b) and (d) via the abdomen. 